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FDA reveals proposed graphic warnings for cigarette packs and ads

Warning labels on cigarette packages could soon be more graphic, warning that "Smoking reduces blood flow to the limbs, which can require amputation," and "S...

Posted: Aug 15, 2019 3:20 PM
Updated: Aug 15, 2019 10:00 PM

Warning labels on cigarette packages could soon be more graphic, warning that 'Smoking reduces blood flow to the limbs, which can require amputation,' and 'Smoking causes bladder cancer, which can lead to bloody urine.'

The US Food and Drug Administration on Thursday issued a proposed rule that requires tobacco companies to place new graphic health warnings on cigarette packages and in advertisements. The proposed warnings feature color images and describe the health risks of smoking.

The new cigarette health warnings, once finalized, would appear on cigarette packages and in advertisements, occupying the top 50% of the area of the front and back panels of packages and at least 20% of the area at the top of cigarette ads, according to the FDA.

This draft version of the rule comes after a judge ordered last year that the FDA has 'delayed' issuing a rule mandating such graphic warnings. The final version of the rule is due to be issued by March 15, 2020. The warnings then would appear on products and in advertisements 15 months after the final rule is issued.

There are 13 proposed warnings, which feature text statements accompanied by color images, and they represent the most significant change to cigarette labels in the United States in 35 years, according to the FDA.

'While most people assume the public knows all they need to understand about the harms of cigarette smoking, there's a surprising number of lesser-known risks that both youth and adult smokers and nonsmokers may simply not be aware of, such as bladder cancer, diabetes and conditions that can cause blindness,' Dr. Ned Sharpless, acting FDA commissioner, said in a written statement on Thursday.

'With these new proposed cigarette health warnings, we have an enormous public health opportunity to fulfill our statutory mandate and increase the public's understanding of the full scope of serious negative health consequences of cigarette smoking,' he said. 'Given that tobacco use is still the leading cause of preventable disease and death in the U.S., there's a lot at stake to ensure the public understands these risks.'

'It's way past time for this to happen'

The United States will join at least 120 other countries and jurisdictions that have finalized requirements for warning labels that include pictures to be printed on cigarette packages, according to the advocacy organization Campaign for Tobacco-Free Kids.

Pictorial warning labels on cigarette packs could reduce smoking prevalence by 5% in the short term and 10% over the long term in the United States, according to a study published in the journal Tobacco Control in 2016.

The study projected that over the next 50 years, pictorial warning labels could avert 652,800 smoking-attributable deaths, 46,600 cases of low birth weight, 73,600 preterm births and 1,000 cases of sudden infant death syndrome.

'It's very clear that half of the people who currently use tobacco products die from using them. It's 480,000 people each year in the United States,' said Mary Rouvelas, senior counsel for the American Cancer Society Cancer Action Network, which is the advocacy affiliate of the society.

'This is a proven mechanism that keeps people from picking up cigarettes and helps them quit -- or I should say helps increase the number of quit attempts,' she said about graphic warning labels.

Tobacco use is the leading cause of preventable disease, disability and death in the United States, according to the US Centers for Disease Control and Prevention.

'We just believe that it's way past time for this to happen and we're very glad that the FDA looks like it's moving forward,' Rouvelas said.

American Cancer Society Cancer Action Network was among physician groups, anti-tobacco groups and others that sued the FDA in 2016 claiming that the agency delayed taking action on a rule to implement graphic warnings as required under the Tobacco Control Act, which became law in 2009.

American Heart Association CEO Nancy Brown said in a statement Thursday, 'The FDA's years-long delay in issuing these proposed warnings extended the life of the old, ineffective labels for far too long.'

Tobacco companies respond

R.J. Reynolds Tobacco Company, which is among the tobacco companies that would be impacted by this FDA rule, said in a statement on Thursday that the company is reviewing the FDA's latest proposal for graphic warnings.

'We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers,' Kaelan Hollon, a spokesperson for Reynolds American Inc., said in the emailed statement. RAI is the parent company of R.J. Reynolds Tobacco Company in the United States.

'As FDA considers how it chooses to communicate cigarette information, we encourage the agency to publicize the comparative risks of other tobacco products to the public so that adults who wish to continue to use them can make fully informed decisions between product options in the tobacco category,' the statement said in part. 'RAI is committed to promoting tobacco harm reduction, in other words, identifying consumer-acceptable tobacco products that may present less harm than conventional tobacco-burning cigarettes.'

Altria, which owns Philip Morris USA, the maker of Marlboro cigarettes, said in a separate emailed statement that the company 'will carefully review the proposed rule and its implications to our businesses and submit comments.'

More than 40 million adults in the United States still smoke cigarettes, according to the CDC, and about 4.7 million middle and high school students use at least one type of tobacco product, including e-cigarettes.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 710607

Reported Deaths: 13248
CountyCasesDeaths
Marion968581722
Lake51908949
Allen39337672
Hamilton34643406
St. Joseph34306543
Elkhart27477432
Vanderburgh22099394
Tippecanoe21927213
Porter17987301
Johnson17571374
Hendricks16854310
Clark12715190
Madison12367337
Vigo12240244
Monroe11510166
LaPorte11204204
Delaware10382184
Howard9698211
Kosciusko9165114
Hancock8014139
Bartholomew7913155
Warrick7702155
Floyd7568176
Wayne6917198
Grant6855171
Boone6568100
Morgan6414138
Dubois6091117
Marshall5801109
Dearborn571276
Cass5698104
Henry5588101
Noble543683
Jackson494172
Shelby481395
Lawrence4349118
Gibson429589
Harrison429171
Clinton420953
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Whitley382239
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Miami373365
Knox367189
Steuben367157
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Washington231631
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Sullivan208042
Starke206252
Owen192756
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Jay186429
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Martin83115
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Union70110
Ohio56011
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Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1058395

Reported Deaths: 19033
CountyCasesDeaths
Franklin1229981360
Cuyahoga1080042072
Hamilton785031170
Montgomery50326998
Summit45710915
Lucas40568768
Butler37858572
Stark31586896
Lorain24333473
Warren23964293
Mahoning21029584
Lake20143365
Clermont19480229
Delaware18162130
Licking16185207
Fairfield15796197
Trumbull15666461
Medina14961259
Greene14765236
Clark13697293
Wood12828185
Portage12481196
Allen11374229
Richland11102198
Miami10568214
Muskingum8729127
Wayne8619209
Columbiana8589226
Pickaway8454121
Marion8409135
Tuscarawas8393240
Erie7644154
Hancock6746124
Ross6727146
Ashtabula6563166
Geauga6563146
Scioto6314101
Belmont5657159
Union560247
Lawrence5483102
Jefferson5372149
Huron5333114
Darke5285121
Sandusky5208120
Seneca5163120
Washington5095108
Athens509256
Auglaize477683
Mercer473785
Shelby458092
Knox4418108
Madison426559
Putnam423199
Ashland414488
Fulton411667
Defiance405596
Crawford3894102
Brown387755
Logan375176
Preble372498
Clinton364060
Ottawa359578
Highland348460
Williams330074
Champaign322357
Jackson309351
Guernsey308749
Perry290949
Fayette278448
Morrow277239
Hardin265964
Henry265066
Coshocton261058
Holmes255199
Van Wert239863
Pike234231
Gallia233346
Adams230252
Wyandot228354
Hocking210759
Carroll189747
Paulding169239
Meigs141738
Noble133037
Monroe129041
Morgan107723
Harrison105936
Vinton81614
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